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I.S. EN 13826:2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PEAK EXPIRATORY FLOW METERS
Available format(s)

Hardcopy , PDF

Superseded date

27-08-2007

Language(s)

English

Published date

01-01-2003

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
   4.1 Electrical safety
   4.2 Mechanical safety
5 Identification, marking and documents
   5.1 Marking of the scale or display
   5.2 Marking of PEFM or packaging
   5.3 Accompanying documents
   5.4 Technical description
6 PEFM measurement ranges
7 Performance requirements
   7.1 Error of measurement
   7.2 Linearity
   7.3 Resistance to flow
   7.4 Frequency response
8 Dismantling and reassembly
9 Effects of mechanical ageing
10 Effects of dropping hand-held PEFM
Annex A (normative) - Method of determining error, repeatability
                      and resistance to flow of peak expiratory
                      flow meter output
      A.1 - Principle
      A.2 - Apparatus
      A.3 - Procedure
      A.4 - Calculations
      A.5 - Test report
      A.6 - Pass/fail criteria
Annex B (normative) - Method of determining frequency response
      B.1 - Principle
      B.2 - Apparatus
      B.3 - Procedure
      B.4 - Calculations for frequency response
      B.5 - Test report
      B.6 - Pass/fail criteria
Annex C (normative) - Test methods for determining the effects of
                      dismantling, ageing and dropping
      C.1 - Principle
      C.2 - Apparatus
      C.3 - Procedures
      C.4 - Calculation of effects
      C.5 - Test report
Annex D (informative) - Rationale for tests and examples of test
                        apparatus
      D.1 - Introduction
      D.2 - General
      D.3 - Apparatus
Annex ZA (informative) - Clauses of this European standard
                         addressing essential requirements or other
                         provisions of EU directives
Bibliography

Gives requirements for peak expiratory flow meters (PEFM) intended for the assessment of pulmonary function in spontaneously breathing humans.

DocumentType
Standard
Pages
26
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
NS EN 13826 : 1ED 2003 Identical
NF EN 13826 : 2003 Identical
BS EN 13826:2003 Identical
UNI EN 13826 : 2004 Identical
SN EN 13826 : 2003 Identical
NBN EN 13826 : 2003 Identical
UNE-EN 13826:2004 Identical
NEN EN 13826 : 2003 Identical
EN 13826 : 2003 Identical
DIN EN 13826:2003-09 Identical

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 980:2008 Symbols for use in the labelling of medical devices

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